Alkermes plc (NASDAQ: ALKS) today announced the initiation of a phase 1 clinical study of ALKS 7106, a proprietary, novel, oral, small-molecule drug candidate for the treatment of pain. The randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability and pharmacokinetics of ALKS 7106 in approximately 80 healthy, male adults. ALKS 7106 represents a new class of analgesic agents in development at Alkermes: potent opioid modulators designed for the treatment of pain with intrinsically low potential for abuse and overdose death – two liabilities associated with opioid analgesics. ALKS 7106’s potential attributes derive from its intrinsic mechanism of action in the brain rather than through the use of abuse-deterrent technologies or formulations.
“Pain relievers are some of the most prescribed medicines in America, and there is a significant need for new opioid treatment options for pain that can provide analgesic effect with lower abuse potential and risk of overdose, compared to conventional opioid pain medications,” said Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. “Based on preclinical studies, ALKS 7106 appears to have intrinsic properties that may address these serious risks while maintaining analgesic effect, and we look forward to determining whether these findings are also observed in the clinic.”
This phase 1, randomized, double-blind, placebo-controlled, single-ascending-dose, multi-cohort, four-week study will evaluate the safety, tolerability and pharmacokinetics of ALKS 7106 administered orally in approximately 80 healthy, male adults. Results from this phase 1 study are expected in the first half of 2015.
About ALKS 7106
ALKS 7106 is
Alkermes’ novel, oral opioid analgesic drug candidate designed for the
treatment of pain with intrinsically low potential for abuse and
overdose death. In preclinical models, ALKS 7106 was shown to be highly
potent, with similar efficacy to morphine at a 30-fold lower dose, and
was well tolerated at doses far in excess of those required for
analgesic action. Additional preclinical data for ALKS 7106 demonstrated
a ceiling effect on neurotransmitter release over a broad concentration
range, suggesting low potential for abuse and overdose death.
About Alkermes
Alkermes plc is
a fully integrated, global biopharmaceutical company that applies its
scientific expertise and proprietary technologies to develop innovative
medicines that improve patient outcomes. The company has a diversified
portfolio of more than 20 commercial drug products and a substantial
clinical pipeline of product candidates that address central nervous
system (CNS) disorders such as addiction, schizophrenia and depression.
Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in
Waltham, Massachusetts; a research and manufacturing facility in
Athlone, Ireland; and manufacturing facilities in Gainesville, Georgia
and Wilmington, Ohio. For more information, please visit Alkermes’
website at www.alkermes.com.
Note Regarding Forward-Looking Statements
Certain
statements set forth in this press release constitute “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995, as amended, including, but not limited to,
statements concerning: the therapeutic value, development plans and
commercial potential of ALKS 7106. The company cautions that
forward-looking statements are inherently uncertain. Although the
company believes that such statements are based on reasonable
assumptions within the bounds of its knowledge of its business and
operations, the forward-looking statements are neither promises nor
guarantees and they are necessarily subject to a high degree of
uncertainty and risk. Actual performance and results may differ
materially from those projected or suggested in the forward-looking
statements due to various risks and uncertainties. These risks and
uncertainties include, among others: whether preclinical and early
clinical results for ALKS 7106 will be predictive of future clinical
study results; whether future clinical trials for ALKS 7106 will be
completed on time or at all; changes in the cost, scope and duration of
the ALKS 7106 clinical trials; whether ALKS 7106 could be ineffective or
unsafe during clinical studies, and whether, in such instances, Alkermes
may not be permitted by regulatory authorities to undertake new or
additional clinical studies for ALKS 7106; and those risks described in
the Alkermes plc Transition Report on Form 10-K for the fiscal period
ended Dec. 31, 2013, and in other subsequent filings made by the company
with the U.S. Securities and Exchange Commission (SEC), which are
available on the SEC’s website at www.sec.gov.
The information contained in this press release is provided by the
company as of the date hereof, and, except as required by law, the
company disclaims any intention or responsibility for updating or
revising any forward-looking information contained in this press release.
Contacts:
For Investors:
Rebecca Peterson, +1 781-609-6378
or
For
Media:
Jennifer Snyder, +1 781-609-6166